NDA 020726

NOVARTIS PHARMS

FDA Drug Application

Application #020726

Documents

• Letter: 2004-06-04
• Letter: 2006-01-06
• Letter: 2007-04-20
• Letter: 2010-03-08
• Letter: 2010-05-06
• Label: 2003-03-04
• Label: 2001-01-10
• Label: 2003-01-17
• Label: 2004-10-29
• Label: 2010-03-03
• Label: 2010-03-03
• Label: 2010-07-01
• Label: 2010-05-06
• Label: 2014-01-16
• Review: 2001-01-10
• Letter: 2003-03-10
• Letter: 2001-01-10
• Letter: 2005-01-26
• Letter: 2006-06-27
• Letter: 2010-03-08
• Letter: 2008-08-13
• Letter: 2009-07-17
• Letter: 2010-06-29
• Letter: 2012-01-03
• Letter: 2014-01-17
• Label: 2006-01-05
• Label: 2007-04-20
• Label: 2009-07-09
• Label: 2011-12-23
• Review: 2003-08-07
• Letter: 2017-07-17
• Label: 2017-07-19
• Letter: 2018-04-06
• Label: 2018-04-09

Application Sponsors

NDA 020726

NOVARTIS PHARMS

Marketing Status

• Prescription: 001

Application Products

001

TABLET;ORAL

2.5MG

1

FEMARA

LETROZOLE

FDA Submissions

TYPE 1; Type 1 - New Molecular Entity	ORIG	1	AP	1997-07-25	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	2	AP	1999-04-22	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	3	AP	2001-02-05	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	4	AP	2000-05-23	STANDARD
EFFICACY; Efficacy	SUPPL	5	AP	2003-02-26	STANDARD
EFFICACY; Efficacy	SUPPL	6	AP	2001-01-10	PRIORITY
MANUF (CMC); Manufacturing (CMC)	SUPPL	7	AP	2002-01-10	STANDARD
EFFICACY; Efficacy	SUPPL	8	AP	2003-01-17	STANDARD
EFFICACY; Efficacy	SUPPL	11	AP	2004-10-29	UNKNOWN
EFFICACY; Efficacy	SUPPL	12	AP	2005-12-28	PRIORITY
LABELING; Labeling	SUPPL	13	AP	2006-06-26	STANDARD
LABELING; Labeling	SUPPL	14	AP	2007-04-11	STANDARD
EFFICACY; Efficacy	SUPPL	15	AP	2010-03-02	UNKNOWN
EFFICACY; Efficacy	SUPPL	16	AP	2010-03-02	UNKNOWN
LABELING; Labeling	SUPPL	17	AP	2008-08-07	STANDARD
LABELING; Labeling	SUPPL	18	AP	2009-07-07	STANDARD
LABELING; Labeling	SUPPL	19	AP	2010-06-25	STANDARD
EFFICACY; Efficacy	SUPPL	20	AP	2010-04-30	STANDARD
LABELING; Labeling	SUPPL	24	AP	2011-12-23	UNKNOWN
MANUF (CMC); Manufacturing (CMC)	SUPPL	25	AP	2013-07-11	STANDARD
LABELING; Labeling	SUPPL	27	AP	2014-01-15	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	29	AP	2015-12-23	STANDARD
MANUF (CMC); Manufacturing (CMC)	SUPPL	30	AP	2016-10-28	STANDARD
LABELING; Labeling	SUPPL	33	AP	2017-07-13	STANDARD
LABELING; Labeling	SUPPL	35	AP	2018-04-05	STANDARD

Submissions Property Types

SUPPL	1	Null	0
SUPPL	2	Null	0
SUPPL	3	Null	0
SUPPL	4	Null	0
SUPPL	7	Null	0
SUPPL	11	Null	41
SUPPL	12	Null	41
SUPPL	15	Null	6
SUPPL	16	Null	6
SUPPL	19	Null	7
SUPPL	20	Null	7
SUPPL	24	Null	6
SUPPL	25	Null	0
SUPPL	27	Null	7
SUPPL	29	Null	0
SUPPL	33	Null	15
SUPPL	35	Null	15

TE Codes

001

Prescription

AB

CDER Filings

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